Methods for Localization of Cancerous Tissue Using Fluorescent Molecular Imaging Agent for Diagnosis or Treatment

Abstract

Methods are provided that include navigating an instrument, via a minimally invasive route (e.g., an endoluminal procedure), into a patient to whom a molecular imaging agent has been intravenously administered, to position the instrument in an area of a tissue abnormality; and visualizing, via the instrument, tissue in the area under near-infrared (NIR) light, wherein the molecular imaging agent, as administered, causes abnormal tissue in the area to fluoresce under the NIR light and enable the fluorescing abnormal tissue to be localized within the area. The method may further include diagnosing and/or treating the fluorescing abnormal tissue.

That which is claimed is: 
     
         1 . A method comprising:
 navigating an instrument, via a minimally invasive route, into a human patient to whom a molecular imaging agent has been intravenously administered, to position the instrument in an area of a tissue abnormality; and   visualizing, via the instrument, tissue in the area under near-infrared (NIR) light, wherein the molecular imaging agent, as administered, causes abnormal tissue in the area to fluoresce under the NIR light and enable the fluorescing abnormal tissue to be localized within the area,   wherein the molecular imaging agent comprises VGT-309 or a pharmaceutically acceptable salt thereof, and   wherein the molecular imaging agent is administered to the patient at a dose from 0.01 mg/kg to 0.7 mg/kg between 2 hours and 4 days prior to the navigating.   
     
     
         2 . The method of  claim 1 , wherein the molecular imaging agent is administered between 72 hours and 96 hours prior to the navigating. 
     
     
         3 . The method of  claim 1 , wherein the dose is from 0.015 mg/kg to 0.65 mg/kg. 
     
     
         4 . The method of  claim 1 , wherein the dose is from 0.1 mg/kg to 0.4 mg/kg. 
     
     
         5 . The method of  claim 1 , wherein the dose is from 0.015 mg/kg to 0.65 mg/kg and is administered between 72 hours and 96 hours prior to the navigating. 
     
     
         6 . The method of  claim 1 , wherein the fluorescing abnormal tissue is in the patient's lungs. 
     
     
         7 . The method of  claim 6 , wherein the fluorescing abnormal tissue comprises a nodule external to a bronchus. 
     
     
         8 . The method of  claim 6 , wherein:
 the instrument comprises a flexible bronchoscope, and   the navigating comprises guiding the flexible bronchoscope through the patient's airway.   
     
     
         9 . The method of  claim 1 , further comprising diagnosing and/or treating the fluorescing abnormal tissue. 
     
     
         10 . The method of  claim 1 , wherein the navigating, via a minimally invasive route, is an endoluminal procedure. 
     
     
         11 . The method of  claim 1 , wherein the area of the tissue abnormality is identified from one or more preoperative scans. 
     
     
         12 . The method of  claim 1 , wherein:
 the instrument comprises a biopsy needle or other biopsy tool; and   the diagnosing and/or treating comprises collecting one or more biopsy samples from the fluorescing abnormal tissue.   
     
     
         13 . The method of  claim 1 , wherein the diagnosing and/or treating comprises resection or destruction of the fluorescing abnormal tissue. 
     
     
         14 . The method of  claim 13 , wherein the destruction of the fluorescing abnormal tissue comprise (i) ablation, and/or (ii) local administration of a drug to the fluorescing abnormal tissue. 
     
     
         15 . The method of  claim 1 , which is done without a preoperative marking procedure. 
     
     
         16 . The method of  claim 1 , wherein the navigating the instrument comprises use of a robotic or robotically-assisted system. 
     
     
         17 . A method comprising:
 navigating an instrument, via an endoluminal route, into a patient to whom VGT-309 or a pharmaceutically acceptable salt thereof has been intravenously administered, to position the instrument in a target area;   visualizing, via the instrument, the target area under near-infrared (NIR) light; and   identifying in real time the location of any abnormal or cancerous tissue within the target area by the florescence of the abnormal or cancerous tissue caused by the VGT-309 under the NIR light.   
     
     
         18 . The method of  claim 17 , wherein the VGT-309 is administered between 2 hours and 4 days prior to the navigating. 
     
     
         19 . The method of  claim 17 , wherein the VGT-309 is administered between 12 hours and 36 hours prior to the navigating. 
     
     
         20 . The method of  claim 17 , wherein the VGT-309 is administered between 72 hours and 96 hours prior to the navigating. 
     
     
         21 . The method of  claim 17 , wherein the VGT-309 is administered to the patient at a dose from 0.015 mg/kg to 0.65 mg/kg. 
     
     
         22 . The method of  claim 17 , wherein the VGT-309 is administered to the patient at a dose from 0.015 mg/kg to 0.65 mg/kg between 48 hours and 96 hours prior to the navigating. 
     
     
         23 . The method of  claim 17 , wherein the VGT-309 is administered to the patient at a dose from 0.1 mg/kg to 0.4 mg/kg between 48 hours and 96 hours prior to the navigating. 
     
     
         24 . The method of  claim 17 , wherein the VGT-309 is administered to the patient at a dose from 0.015 mg/kg to 0.65 mg/kg between 72 hours and 96 hours prior to the navigating. 
     
     
         25 . The method of  claim 17 , wherein the navigating the instrument comprises use of a robotic or robotically-assisted system.